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SICK: Serological Identification of Celiac Disease in Kids

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Completed
CT.gov ID
NCT03966625
Collaborator
Vastra Gotaland Region (Other)
496
Enrollment
2
Locations
19.9
Actual Duration (Months)
248
Patients Per Site
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to examine the feasibility of incorporating serological celiac disease (CD) screening into general pediatric outpatient clinics in Sweden and through structured monitoring examine the effects of diagnosing and treating screening-detected CD.

Screening will be tailored to general pediatric outpatient clinics in the Gothenburg metropolitan area with the goal to screen 1000 children over four months. Screening for CD will be carried out by measuring tissue transglutaminase autoantibodies (TGA) in blood. Children who are persistently TGA positive will be enrolled into a 6-12-month follow-up protocol responsible for diagnosing CD, installation of gluten-free diet and to assess their short-term impact upon the child's wellbeing. Other components to assess include (I) the feasibility to incorporate CD screening into busy pediatric practices; (II) parental/child interest in, and satisfaction with, participating in a CD screening program and (III) identifying key considerations for a possible scaled-up, broad-based, CD screening.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: tissue transglutaminase autoantibodies

Study Design

Study Type:
Observational
Actual Enrollment :
496 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Serological Identification of Celiac Disease in Kids (Swedish: Screening för Celiaki på Barnmottagning)
Actual Study Start Date :
Nov 4, 2019
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Number of participants diagnosed with celiac disease [Assessed after 6-12 months of follow-up]

    Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines

Secondary Outcome Measures

  1. Number of participants identified with celiac disease autoimmunity [Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment)]

    Celiac disease autoimmunity defined by having two consecutive positive tests for tissue transglutaminase (TTG) autoantibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Aged 2-17 years old

  • Patient at pediatric outpatient clinics in Gothenburg metro area

  • Parental and adolescent consent to screening

Exclusion Criteria for serological screening:

  • Established celiac disease diagnosis

  • Type 1 diabetes

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Slivia Children's Hosptial Gothenburg Sweden 41650
2 BUMM Hisingen Gothenburg Sweden

Sponsors and Collaborators

  • Sahlgrenska University Hospital, Sweden
  • Vastra Gotaland Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karl Mårild, Pediatrican, associate professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT03966625
Other Study ID Numbers:
  • DSBUS
First Posted:
May 29, 2019
Last Update Posted:
Dec 9, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karl Mårild, Pediatrican, associate professor, Sahlgrenska University Hospital, Sweden
screening
Additional relevant MeSH terms:
Celiac Disease
Autoantibodies

Study Results

No Results Posted as of Dec 9, 2021